RecruitingPhase 1NCT07107490

A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER

AN OPEN-LABEL, MULTICENTER PHASE I STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER


Sponsor

Chugai Pharmaceutical

Enrollment

122 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a phase I, open-label, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of ALPS12 in patients with extensive-stage small cell lung cancer. The study consists of two parts: a dose-escalation part and an expansion part.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase I study is testing a new drug called ALPS12 in people with extensive-stage small cell lung cancer (SCLC) — an aggressive form of lung cancer that has spread beyond the chest. The trial is in the early stages, focused on safety and finding the right dose. **You may be eligible if:** - You are older than 18 - You have been diagnosed with extensive-stage small cell lung cancer confirmed by biopsy - Your cancer has come back or progressed after at least one prior treatment - Your overall health is good (ECOG 0–1) - You have measurable disease on imaging - Your blood counts and organ function are adequate - A tumor sample (archived or fresh) is available for testing **You may NOT be eligible if:** - You are pregnant or breastfeeding - You have a history of significant autoimmune disease - You test positive for HIV - You have active hepatitis B or C - You have previously been treated with certain immune-activating drugs (anti-CD137 or anti-CD3 antibodies) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALPS12

ALPS12 as an IV infusion

DRUGobinutuzumab

Obinutuzumab as an IV infusion


Locations(6)

Queen Mary Hospital

Hong Kong, Hong Kong

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Ehime University Hospital

Tōon, Ehime, Japan

Kindai University Hospital

Sakai, Osaka, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Show Chwan Memorial Hospital

Changhua, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07107490


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